MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; CATHETER, IRRIGATION

Model Number	SU130-0323
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A non-conformance/device history record review could not be conducted because a lot number was not provided.Therefore, a review of the specific manufacturing and inspection records was not possible.However, all product lots are required to meet established acceptance criteria and must successfully pass defined visual and functional inspections prior to release.There were no samples returned for evaluation; therefore, the affected device could not be evaluated to confirm the reported issue.However, a corrective and preventative action has been opened to further investigate and address the reported condition.
Event or Problem Description
Patient had an elective laminectomy and fusion surgery.Patient returned to the hospital post procedure after being discharged.Ct imaging revealed a surgical drain fragment in the laminectomy bed region with its proximal end in the subcutaneous soft tissues just beneath the skin.Patient returned to surgery for removal of retained drain fragment.A surgical drain/drain fragment is suggested in the region of the laminectomy bed with its proximal end in the subcutaneous soft tissues just beneath the skin.No further information was provided.

• Brand Name: CARDINAL HEALTH
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): PR006 PUERTO RICO-ANASCO; state rd. 402 , north km 0.9; anasco PR 00610
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 25194342
• Report Number: 1423537-2026-00160
• Device Sequence Number: 21440898
• Product Code: GBX
• UDI-Device Identifier: 10192253022247
• UDI-Public: (01)10192253022247
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: SU130-0323
• Device Catalogue Number: SU130-0323
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 05/15/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 69 KG
• Patient Race: White